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510(k) Data Aggregation
K Number
K032594Device Name
ONE DIMENSIONAL WATER PHANTOM, WP 1D
Manufacturer
WELLHOFER DOSIMETRIE
Date Cleared
2003-09-05
(14 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
WELLHOFER DOSIMETRIE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Clinical Reference Dosimetry Phantom WP 1D is used to position various radiation detectors in water or air. It consists of a cubic tank and a precision onedimensional hand crank or motor driven servo. By design it is suitable to act as a phantom according to various dosimetric protocols (e.g. AAPM's TG-51 or IAEA's TRS-398). The device is intended to be used by experienced professionals entrusted with dosimetric functions only.
Device Description
The Clinical Reference Dosimetry Phantom WP 1D comprises a one-dimensional precision servomechanism attached to a Perspex (PMMA) water tank. Various radiation detectors can be positioned along a vertical guide rail in different depths according to the application needs.
The "Manual Version" consists of the basic phantom, equipped with a self-locking hand crank to move the detector. That hand crank is coupled to a battery powered, reset-able position indicator that displays the depth.
The "SCU Version" consists of the basic phantom, equipped with a motor/potentiometer device to move the detector. An electronic servo control unit (SCU) consisting of a handheld Remote Control and a Motor Control unit is used to position the detector to a user definable or stored depth.
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K Number
K031634Device Name
OMNIPRO I'MRT
Manufacturer
WELLHOFER DOSIMETRIE
Date Cleared
2003-08-29
(94 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
WELLHOFER DOSIMETRIE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the OmniPro I'mRT system is to:
• verify the treatment plan and delivered dose of intensity modulated or static beams prior to treatment
• verify the intensity maps during IMRT delivery prior to treatment
• verify the absolute dose in given points for IMRT fields.
Device Description
The Scanditronix & Wellhöfer OmniPro I'mRT system is a system similar to Radiological Imaging Technology: RIT113 Film Analysis System FDA K935928 12/13/1993
The OmniPro I'mRT system and the marketed predicated product are radiotherapy quality assurance systems designed to measure dose, doseor intensity-distributions, to analyse these data and to compare the measurement data with calculated dose- or intensity-distributions, especially in the field of Intensity Modulated Radiotherapy.
The OmniPro I'mRT system can consist of
- software (herafter called OmniPro I'mRT) .
- hardware supported by OmniPro I'mRT (like detector arrays, . filmscanning devices, single detectors, bodyphantoms for positioning and pacing of film and/or detectors or detector arrays).
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